Revolution Medicines gets FDA nod for targeted pancreatic cancer drug

Reuters

(CNN) — The U.S. Food and Drug Administration on Wednesday approved Revolution Medicines’ targeted drug for adults with ​metastatic pancreatic cancer who have received prior treatment or ‌cannot receive combination chemotherapy.

The drug, branded as Rasonque and also known as daraxonrasib, is a once-daily pill designed to block several forms of the RAS protein, ​which helps drive tumor growth in many pancreatic cancers.

Rasonque, ​a first-in-class cancer drug, was included in the FDA Commissioner’s National ⁠Priority Voucher program, designed to accelerate reviews from the usual ​10 to 12 months to as little as one to two ​months for therapies that address major U.S. health priorities and substantial unmet medical needs.

Given the lack of effective treatment options for pancreatic cancer, the FDA approval ​for Revolution marks a significant advance in a disease area with ​a five-year survival rate of about 13%, one of the lowest among major ‌cancers, ⁠according to the American Cancer Society.

The approval was based on a study of 500 adults with previously treated metastatic pancreatic adenocarcinoma, the most common type of pancreatic cancer. The drug improved the ​rate of overall ​survival to 13.2 ⁠months, compared with 6.7 months on standard chemotherapy.

The FDA had previously granted early access to the drug under a program ​which allows patients with serious or life threatening conditions ​to ⁠receive experimental treatments outside clinical trials prior to authorization by the regulator.

The drug’s most common side effects included rash, diarrhea, mouth inflammation, nausea, ⁠tiredness, ​vomiting, abdominal pain, swelling, reduced appetite and ​bleeding.

Revolution Medicines did not immediately respond to a Reuters request for comment on pricing ​and availability.

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